October 21, 2007

Firms doing drug trials may tie up with Hospitals

The government is planning to make it mandatory for companies doing clinical trails to tie up with hospitals equipped with trained medical professionals.

This provision may feature in the new legislation to enforce ethical practices for clinical trails which is set to tabled in Parliament by the year-end. The is expected to prevent the exploitation of people who volunteer to have new drugs tested on them.

“We want to ensure data integrity by introducing ethical practices in laboratories and data compilation to prevent tampering of essential medical records. Besides this, the proposed law will have detailed guidelines on how to deal with clinical trial volunteers,” the DCGI M Venkateswarulu told ET on the sidelines of the ISB Pharma Summit here on Wednesday.

India’s clinical trials is estimated at $200 million and is expected to grow to $1 billion by 2010. The market has grown at almost 400% in the past two years and is pegged to grow even more by 2010. This means that the regulation is necessary not only to protect individual interests but also provide a quality benchmark for global pharma majors to outsource this function to India, he said.

Companies are realising the value of 80% reduction in costs and hence outsourcing this business to India. Right now, the government does not allow phase III trials to protect patients from possible exploitation.

However, it may consider opening up market for such trials once the legislation is in place. Phase III trials are conducted at random yet controlled multi-centres on large patient groups (3003,000 or more depending upon the disease or medical condition studied).

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